Atomiser for fluids

ABSTRACT

The present invention relates to a new atomizer for nasal or oral application of a medicinal-pharmaceutical aerosol, wherein the active ingredient formulation is always kept under sterile conditions. It is preferred that moisturizers, medicaments and/or wound healing agents are sprayed from the atomizer into the nose or the mouth.

[0001] The present invention relates to a new atomiser for atomising apharmaceutical fluid for application of a medicinal-pharmaceuticalaerosol, wherein the active ingredient formulation is always kept understerile conditions. The thus-created aerosols can be applied, forexample, nasally, orally, via the ears or onto the skin. Nasalapplication is preferred. Moisturisers, medicaments and/or wound healingagents can be applied via the atomiser.

[0002] With nasal sprays of the hereinbefore-described type—that is,nasal sprays for continuous and repeated use—it is necessary on the onehand for the atomiser to possess a relatively large reservoir of activeingredients, and on the other hand not to be too heavy, so that thespray is not used up too quickly and at the same time the user canalways carry the nasal spray with them.

[0003] Most known nasal sprays comprise a pump attachment and a glassstorage container. Such atomisers have the disadvantage that the netweight, i.e. the weight without the active ingredient formulation, isalready relatively heavy. Making larger quantities of active ingredientformulation available in such atomisers, in part produced from glass,correspondingly leads to comparatively very heavy devices which areunwieldy and uncomfortable for the user. Furthermore, glass isrelatively easily broken, which does not only require increasedattentiveness from the user and which in particular can very stronglyrestrict useability by children, but this fragility also often causesproblems in manufacturing, storage and distribution. For example, thestorage container can easily be broken when it is filled or when thepump attachment is attached to the bottle neck. A further source ofdanger is the labelling and packaging of such a glass bottle. Naturally,transportation and distribution also represent further risks with regardto the fragility of the bottle.

[0004] In other nasal sprays, the storage containers comprise plasticbottles. However, these have the disadvantage that they are notflavour-neutral and are not gas impermeable. Hence oxygen can easilydiffuse into the storage container and lead to oxidation of the activeingredient components.

[0005] Finally, there are other atomisers wherein the active ingredientformulation is always kept at an overpressure in comparison to theoutside environment. On the one hand, such an overpressure is used topropel the active ingredient formulation through the nozzle in theattachment and hence to create the aerosol. The use of pump assembliescan be dispensed with in such cases. On the other hand, the overpressuremeans that no material can enter into the storage container from outsideand hence lead to contamination of the active ingredient formulation.When the attachment of such a device is a pump attachment for manualproduction of the aerosol by means of pumping, this has the disadvantagethat the active ingredient formulation can also flow out from the valvein the attachment when in its position of rest, and in part precipitatesor condenses on the valve where it is microbiologically contaminated. Atthe same time, it is possible for active ingredient formulation toprecipitate on the outlet valve during spraying, or for small quantitiesof water to condense there. Both lead to unsterile fluid precipitatingon the outlet valve and the nozzle and being sprayed into the nose ofthe user when the atomiser is next used.

[0006] Hence the object of the present invention is to provide anatomiser which overcomes the difficulties known from the prior art.

[0007] The object is solved in that an atomiser is provided whichcomprises an aluminium storage container and a pump attachment whichallows manual atomisation by means of a pump movement and sterilisesinflowing air to equalise pressure in the storage container. Here, theactive ingredient formulation is always under normal pressure, anoverpressure is not required.

[0008] Within the framework of the present invention, the pumpattachment must have the following features:

[0009] a snap or crimp closure for fixing onto the storage container;

[0010] a pump channel which can pump fluid from the storage containerinto a pressure chamber;

[0011] a valve which is provided between the storage vessel and thepressure chamber;

[0012] a riser which leads from the pressure chamber to a nozzle;

[0013] a pressure control valve which is connected to the riser andwhich is preferably provided within the riser;

[0014] a nozzle to atomise the fluid;

[0015] a triggering element via which a piston can be operated toproduce the pressure necessary for atomisation in the pressure chamber;

[0016] air inlet points outside of the pump tube or the riser and airinlet paths from outside the pump attachment extending into the storagecontainer;

[0017] oligodynamically-effective substances in and/or along the pathstaken by the fluid in the pump channel and/or riser between the storagecontainer and the nozzle;

[0018] sterilisation means along the path taken by the inflowing air,i.e. between the air inlet openings and the storage container.

[0019] The pump attachment is preferably one such as is for exampledescribed in WO 97/18902 and shown in FIG. 1. The pump attachment (2) isfirmly fixed to the bottle neck (102) via the snap closure (3). Here,the inner edge of the snap closure (4) is pushed over the bead-shapededge (105) of the bottle neck (102). A seal (5) is disposed between thebottle neck and the pump attachment, this seal being formed from e.g.rubber, natural or synthetic caoutchouc or preferably from polyethylene.Fluid can be pumped from the storage container into the pressure chamber(10) via a first pumping channel (25). The pressure chamber (10) can beconfigured as a part of the first pumping channel (25) in its upperarea. A ball valve (11) closes the path of the fluid through the firstpumping channel (25) into the pressure chamber (10). The pressurechamber (10) is a part of the pressure cylinder (8). A piston (6) isdisposed in the pressure cylinder (8) with a further axial pumpingchannel (7). The piston (6) is held against a detent in its upper restposition by the spring (9). The pressure chamber (10) is disposedbetween the piston (6) and the ball valve (11) and is connected with theupper pumping channel (7).

[0020] The piston (6) has a smaller external diameter than the internaldiameter of the pressure cylinder (8), leaving a gap (12) between theexternal wall of the piston and the internal wall of the cylinder whichis sealed by the peripheral sealing body (13) of the piston. In thelower area of the pressure chamber (10), the pressure cylinder (8) hasan area (14) with a larger internal diameter in which the sealing body(13) has no sealing effect.

[0021] A triggering element (15) is disposed on the piston (6) with theupper pumping channel (7). From here, a riser (16), which is connectedto a pressure control valve (17), leads to a nozzle (18) in order tobring the fluid which is to be atomised through the opening of thenozzle. According to the function, the upper pumping channel (7) and theriser (16) form a common riser which connects the pressure chamber tothe nozzle.

[0022] The pressure control valve (17) is connected to the riser (16) insuch a way that the fluid flows around it, at least in part. Thepressure control valve can be disposed at any point within the commonriser, which is formed from the upper pumping channel (7) and the riser(16). In FIG. 1, it is provided in the upper area of the riser (16).

[0023] If the piston (6) is in its upper position of rest, as shown inthe diagram, the sealing body (13) seals the pressure chamber (10) fromthe opening (19) of the storage container. The pushrod (20) is firmlyconnected to the piston (6) in the area (21) and has a star-shapeddiameter so that a free space is left between the pressure chamber (10)and the upper pumping channel (7).

[0024] In the rest position, the pushrod (20) is far removed from theball valve (11) so that this valve is opened with regard to the storagecontainer when enough underpressure is produced in the pressure chamber(10) and the valve is closed when the pressure there is correspondinglyhigh.

[0025] The fluid takes the following path through the pump attachment:firstly it is pumped by the first pumping channel (25) out of thestorage container into the pressure chamber (10) via the open ball valve(11) and then enters the pumping channel (7). From there, the fluidpasses the riser (16) with the pressure control valve (17) disposedthere and finally reaches the nozzle (18).

[0026] In order to avoid biological contamination of the fluid in thestorage container, oligodynamically-effective substances are disposedalong the path taken by the fluid from the storage container to thenozzle.

[0027] These substances can, for example, be formed on the spring (9),on the wall of the upper pumping channel (7) or the riser (16), in thepressure control valve (17) and/or on the nozzle (18).

[0028] In order to equalise pressure in the storage container (101)after drawing out fluid, air can enter the device from the outside atthe points (23) and can then penetrate into the storage container (101),as is shown for example by the arrow (22) in the drawing.

[0029] Means for sterilising the incoming air are formed along theairways. These include, for example, sterility filters, membranes whichare only air-permeable, bacteria-retaining materials,oligodynamically-effective substances or microbiocidically-effectivesubstances, or combinations thereof. By way of example, a sterilityfilter (24) is shown in FIG. 1.

[0030] As already stated, the pump top fitment (2) is connected to thebottle neck (102) via a snap closure (3).

[0031]FIG. 2 shows a variant of FIG. 1, wherein the pressure controlvalve (17) is formed close to the transition area between the upper pumpchannel (7) and the riser (16). The consequence of this arrangement isthat the area of the riser (16) which is disposed between the upper endof the upper pumping channel (7) and the pressure control valve (17) isseverely shortened in comparison to that in FIG. 1, whilst the areabetween the pressure control valve (17) and the opening of the nozzle(18) is clearly lengthened. As soon as the pressure control valve (17)is opened, the opening (26) is released and the fluid can flow from thelower area of the riser (16) which is upstream of the pressure controlvalve (17), past this valve, through the opening (26) and into the upperarea (26) of the riser (16). The nozzle (18) is covered by a push-on cap(27).

[0032] The storage container is an aluminium bottle as shown in FIG. 3.FIG. 4 shows an enlargement of the bottle neck. The storage container(101) comprises the bottle neck (102), the bottle body (103) and theconcave bottle base (104). The bottle neck has a beaded shape (105).Viewed in the direction from the bottle body to the bottle opening, aring-shaped indentation extending perpendicular to the axis isoptionally formed at the start of the bottle neck in order to allow acap to be anchored.

[0033] The bottle neck is generally narrower than the bottle body, theexternal diameter is preferably between 15 and 33 mm, especiallypreferably 18 to 21 mm. In another embodiment, it is preferably 30 to 33mm. The internal diameter is preferably 12 to 28 mm, especiallypreferably between 14 and 16 mm. In another embodiment it is preferably24-26 mm. The height of the bottle is preferably 50 mm to 250 mm,especially preferably 50 mm to 125 mm, most specially preferably 60mm-90 mm.

[0034] The bottle wall has a thickness of 0.3 to 0.5 mm in the wall andneck area, preferably 0.37 to 0.41 mm. The wall thickness of the basearea is 0.5 mm to 1.5 mm, preferably 0.8 to 1 mm.

[0035] The outside of the bottle can be varnished or optionally printed,the inside, including the bottle neck and its upper edge (106), can becoated with a synthetic varnish. This is preferably Epoxiphenol. Thevarnish is advantageous to increase the corrosion resistance of thebottle to the active ingredient formulation and simultaneously toprevent the active ingredient formulation from adopting a metallicflavour.

[0036] In a preferred embodiment, the upper edge (106) of the bottleneck is rolled flat or in a form. This enhances the seal between thebottle neck and the pump attachment seal.

[0037] The advantages of the atomiser according to the invention are tobe found:

[0038] in the relatively low inherent weight of the device itself incomparison to the filled atomiser,

[0039] in the unbreakableness of the storage container, which is ofespecially great significance during attachment of the pump attachmentto the bottle neck,

[0040] in that the active ingredient formulation does not undergo achange in taste as a result of the storage container material,

[0041] in that the storage container is not gas-permeable, so thepharmaceutical stability of the active ingredient formulation is notreduced by gases diffusing in, even over longer storage periods,

[0042] in that the storage container is opaque.

What is claimed is:
 1. An atomiser for atomising a sterile,pharmaceutical fluid, which fluid is not under pressure, comprising a)an aluminium storage container in the shape of a bottle (101) for thefluid, wherein the storage container has a beading (105) on the upperend of the bottle neck (102) and a flat or form-rolled upper edge and b)a pump attachment (2), fitted permanently to the neck of the storagecontainer, for manual atomisation of the fluid by pumping, wherein thepump attachment has the following features: a snap or crimp closure (3)for fixing onto the storage container (101); a pump channel (25) whichcan pump fluid from the storage container into a pressure chamber; avalve (11) which is provided between the storage vessel and the pressurechamber; a riser (7, 16) which leads from the pressure chamber (10) to anozzle (18); a pressure control valve (17) which is connected to theriser; a nozzle (18) to atomise the fluid; a triggering element (15) viawhich a piston (6) can be operated to produce the pressure necessary foratomisation in the pressure chamber (10); air inlet points (23) outsideof the riser (7, 16) and air inlet paths (22) extending from outside thepump attachment into the storage container; oligodynamically-effectivesubstances in and/or along the paths taken by the fluid in the pumpchannel and/or riser between the storage container and the nozzle;sterilisation means (24) along the path taken by the inflowing air, i.e.between the air inlet openings and the storage container.
 2. An atomiseraccording to claim 1, characterised in that the external diameter of thebottle neck is between 15 and 33 mm, preferably 18 to 21 mm or 30 to 33mm.
 3. An atomiser according to claim 1, characterised in that theinternal diameter of the bottle neck is 12 to 28 mm, preferably 14 to 16mm or 24 to 26 mm.
 4. An atomiser according to claim 1, characterised inthat the wall of the storage container has a thickness in the wall andneck area of 0.3 to 0.5 mm, preferably 0.37 to 0.41 mm, and has athickness in the base area of 0.5 to 1.5 mm, preferably 0.8 to 1 mm. 5.An atomiser according to claim 1, characterised in that the bottle neckhas an annular indentation extending perpendicular to the axis.
 6. Anatomiser according to claim 1, characterised in that the storagecontainer, including the neck and the upper edge of the neck, arevarnished on the inside.
 7. An atomiser according to claim 1,characterised in that the upper edge of the storage container is finelyground flat.
 8. An atomiser according to claim 1, characterised in thata seal made from rubber or natural or synthetic caoutchouc, orpolyethylene, is disposed between the bottle neck and the pumpattachment.
 9. An atomiser according to claim 1, characterised in thatthe bottle height is about 50 to about 250 mm.
 10. An atomiser accordingto claim 9, characterised in that the bottle height is about 50 to about125 mm.
 11. An atomiser according to claim 10, characterised in that thebottle height is about 60 to 90 mm.